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Pragmatic trials are studies designed to inform real-world clinical practice. They are often characterized as a focus on the practical aspects of design, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.

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A pragmatic study that involves different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be valid and helps to reduce the chance of bias in the results. However excessive heterogeneity could result in problems with the design of the trial.

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The goal of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They can also be a great method of determining the causality between an intervention and its outcomes. However, they shouldn't be used to substitute for the use of explanation studies.

The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool attempted to define the features of a pragmatic trial that include recruitment, design and delivery of the intervention, and follow-up.

There is an encouraging increase in the number pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) resulted in 34 articles, shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of studies were conducted in primary-care settings.